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Quality Management Systems (QMS) Requirements

Quality Management Systems Requirements: An Overview

Recent research suggests that quality management system (QMS) software components rank as a top strategic priority for regulated companies. This increased demand coupled with a large vendor landscape can make it difficult to determine which systems offer the greatest value and the easiest implementation. If you are in the market for an automated QMS, you can streamline your search by considering only those solutions that meet certain quality management system requirements that all good systems share. These QMS requirements are discussed throughout this page, and in the complementary information below.

Quality Management System Requirements: What to Look for in a QMS

As regulated companies worldwide demand better ways to manage their quality processes, software vendors are responding to that demand by providing more quality and compliance solutions than ever before. While choice is good, too much choice can complicate the already time consuming and complex QMS vendor selecting process. And investing in the wrong solution, i.e., one that lacks the key quality management system requirements that are critical to success, can be a costly mistake—a mistake that happens more often than you would think. According to Gartner Research, a staggering four out of ten major software purchases are never implemented, resulting in a tremendous waste of financial and human resources.

Failed implementations are typically attributed to two main issues: the system was unable to adapt to the organization’s existing IT and business environments, and the system failed to deliver critical QMS requirements. As you go through the QMS solution/vendor selection process, it’s important to look for the key quality management system requirements that are the hallmarks of a best-of-breed QMS. These requirements include:

Flexibility/Control—Avoid QMS vendors that expect you to redesign proven processes you spent years developing and implementing to accommodate their solution. Your ideal QMS solution should be able to accommodate your organization’s existing business and IT infrastructures, so don’t compromise. Find a solution that’s truly flexible and configurable, and can configure all aspects of the software, including the look-and-feel of the user interface. This is one of the most important QMS requirements. Systems that allow users a high-level of flexibility and control often enjoy the shortest implementation and validation timeframes, as well as the best user adoption rates.

Real Intelligence—The ability to accurately see and measure what’s happening within your quality system is the main benefit of having an automated QMS, as well as a very important quality management system requirement. Make sure the solution that you are considering is up to par in its capabilities for data gathering, processing, searching, and reporting. Be wary as many vendors will claim to offer robust reporting tools, but through a third-party license agreement. This will increase the cost of the system. It’s also important to verify that the types of reports the system generates are relevant to you, or the data will be of little value.

Enterprise Scalability—QMS requirements dictate that the best systems offer users the ability to easily expand the use of the software across the organization without huge license outlays and difficult technical issues. Remember, just because you do not have an immediate need to expand your QMS to include other departments or facilities today, doesn’t mean you won’t in the near future. As you evaluate vendors, and how well they satisfy critical quality management system requirements, it’s important to factor in the solution’s ability to scale to multiple facilities, suppliers, contract manufacturers, and customers.

Seamless Third-party Integration—Keep in mind the integration options available within the QMS. Make sure the system has the ability to connect with the other business systems (e.g., financial systems, production systems) you already have, and can provide a bird’s eye view of all of your operational areas. It is of paramount importance, and one of the most critical QMS requirements, for an organization to be able to integrate its systems. Seamless integration leads to enhanced visibility which, in turn, leads to improved compliance.

Fast, easy implementation—If a software tool is difficult to install or use, regardless of how powerful it is, there is a good chance that it will end up underutilized or never fully implemented. That is why an off-the-shelf, configurable solution like MasterControl is ideal. It fulfills all of the critical quality management system requirements mentioned above, and it allows you to get your quality system up and running quickly, without custom coding, which means you can start meeting your compliance goals almost immediately.

How MasterControl Meets the Top Quality Management System Requirements

Many vendors will insist that their QMS solutions meet critical QMS requirements, but be on the lookout for false claims. As a leading provider of quality management solutions worldwide, MasterControl been designed based on key quality management system requirement best practices to integrate with other enterprise systems quickly and easily. Furthermore, MasterControl allows you to create a single, unified method for managing all of your critical compliance requirements across the enterprise. With robust, integrated quality management solutions from MasterControl, you can manage all of your quality process such as supplier management, CAPA event management risk management, supplier management, and more. Here is how MasterControl’s quality management suite satisfies the QMS requirements outlined in the previous section.

MasterControl meets the “flexibility/control” quality management system requirement: Out-of-the-box and configurable, MasterControl’s flexible system architecture is able to support a variety of IT and business models. This flexible design ensures rapid installation, implementation, and validation, enabling you to jumpstart your compliance goals. Furthermore, MasterControl allows you “brand” the system with your own “look-and-feel” (e.g., incorporate your company logo, customize forms, etc.), without changing the solution’s functionality. Users adapt better to systems when colors and concepts are familiar to them, which is why flexibility is one of the key QMS requirements.

MasterControl meets the “real intelligence” quality management system requirement: To be truly beneficial, a QMS must be able to control and properly document all quality processes. During inspections and audits, quality processes and documents are closely analyzed and serve as a basis for establishing compliance. MasterControl’s document control solution, MasterControl Documents™, provides a centralized, web-based repository for all of your critical documentation. The solution’s robust reporting tool automates the tracking, search, retrieval, routing, review, and approval of documents. In addition, MasterControl Process™ automates any forms-based process, offering best-practice forms that prompt users with selected data to reduce data entry and avoid common data-entry mistakes. Together, the document control and process solutions provide an unparalleled level of “real intelligence” and satisfy critical QMS requirements.

MasterControl meets the “enterprise scalability” quality management system requirement: In today’s dynamic and demand-driven compliance environment, regulated companies must be nimble enough to adapt to ever-evolving regulatory changes. One of the biggest advantages of MasterControl is that it allows organizations to start with a point solution, like MasterControl Documents, that can be easily developed into a full-fledged, fully integrated QMS later on. The ability to integrate core quality processes under a single enterprise platform makes a QMS more transparent to users, auditors, and regulatory inspectors. Because documents and processes are easier to review and maintain, compliance requirements are less likely to be overlooked. All of these benefits should be included in a QMS as they are core QMS requirements.

MasterControl meets the “seamless third-party integration” quality management system requirement: MasterControl has been architected and developed to integrate seamlessly with many major software applications that are commonly used in regulated environments. When properly configured, integration can vastly improve the overall performance of a company’s electronic systems.

MasterControl meets the “fast, easy implementation” quality management systems requirement: Delivering data over the Web is cost-effective and can drastically reduce the time it takes to implement the system. For regulated companies